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ChemoCentryx Reports Second Quarter 2018 Financial Results and Recent Highlights

On August 9, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 9, 2018, View Source [SID1234528752]).

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"A most important milestone has recently been achieved at ChemoCentryx: we completed enrollment of over 300 patients in our landmark ADVOCATE Phase III trial in ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We’re targeting the fourth quarter of 2019 for the release of top-line data from ADVOCATE, and expect that successful trial results would form the basis of our new drug application to the FDA. Our very healthy balance sheet also enables us to simultaneously pursue other high unmet need, high value disease indications. Specifically, controlled clinical trials are underway for avacopan in C3G and for our other innovative kidney asset, CCX140 in FSGS. These are all orphan renal diseases with no approved therapies. Our plan to expand into orphan dermatological disease is also progressing extremely well. We intend to launch a large controlled clinical trial of avacopan in hidradenitis suppurativa later this year. In sum, 2018 is shaping up to be a watershed year for the Company, and we believe our momentum is building."

Recent Highlights

ChemoCentryx has completed enrollment of 316 patients in the Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment.

Expanded commercial alliance with Vifor Pharma to provide Vifor with commercialization rights in China for avacopan and CCX140, in exchange for upfront cash payments to ChemoCentryx totaling $21.5 million, plus tiered royalties between the teens and mid-twenties on potential net future sales in the Vifor territories.

Surpassed 45% of the patient enrollment target in the Company’s clinical trial evaluating avacopan for C3G. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Reported $91.5MM in cash receipts year-to-date; current balance sheet >$200MM in cash and equivalents.

Developed plan to launch clinical trials by the end of 2018 of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.

Launched clinical development of CCR2 inhibitor CCX140 in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option.

Second Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled approximately $201.8 million at June 30, 2018. In the first six months of 2018, ChemoCentryx received $91.5 million in cash from milestone and upfront payments and credit facility advances. Cash utilized for the first six months of the year was $25MM. For the full year, the Company expects to utilize cash and investments between $60 million and $70 million.

Revenue was $15.0 million for the second quarter of 2018, compared to $8.9 million for the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development expenses were $17.8 million for the second quarter of 2018, compared to $14.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the patient enrollment of the avacopan Phase II clinical trial in patients with C3G and start-up expenses related to the CCX140 Phase II clinical trials in patients with FSGS.

General and administrative expenses were $4.7 million for the second quarter of 2018, compared to $4.2 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, partially offset by a decrease in professional fees.

Net loss for the second quarter of 2018 was $6.9 million, compared to $9.2 million for the same period in 2017.

Total shares outstanding at June 30, 2018 were approximately 50.3 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 9, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 6238899. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

AmpliPhi Biosciences Reports Second Quarter 2018 Financial Results and Business Highlights

On August 9, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the second quarter ended June 30, 2018 (Press release, AmpliPhi Biosciences, AUG 9, 2018, View Source [SID1234528749]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial release.

"I’m delighted to report that we have made substantial progress with our expanded access program for AB-SA01 and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "As of today, we have treated a total of nineteen patients at seven different hospitals and we are encouraged by the results. We are analyzing the data and plan to share a more detailed update in the near future. We look forward to our two meetings with the FDA over the next two months, the goal of which is to obtain important clinical development feedback for Phase 2 and potentially pivotal trials in one or more indications."

Recent Business Highlights

Two meetings are scheduled with the FDA for August and September to discuss Phase 2 trial plans and the path forward to regulatory approval for investigational drug candidates AB-SA01, targeting Staphylococcus aureus (S. aureus), and AB-PA01, targeting Pseudomonas aeruginosa (P. aeruginosa).
North America’s first Center for Innovative Phage Applications and Therapeutics (IPATH) was launched by UC San Diego (UCSD) in June 2018 with AmpliPhi as an industry partner. As part of the IPATH launch, UCSD announced the successful case of a patient treated with AmpliPhi’s AB-SA01. Prior to phage therapy, the patient had a persistent S. aureus ventricular assist device infection that was not eradicated for three years despite antibiotic treatment.
Presented four case studies of critically ill patients suffering from severe S. aureus bloodstream infections, who received treatment with AB-SA01, at the American Society for Microbiology (ASM) Microbe 2018 annual meeting in Atlanta in June 2018. In all cases, standard medical and surgical therapy was considered inadequate before starting bacteriophage therapy. AB-SA01 was well-tolerated and bacterial elimination was demonstrated in three out of four patients.
Presented a successful case study of a patient with cystic fibrosis (CF), suffering from recurrent multi-drug resistant (MDR) P. aeruginosa pneumonia and multiple CF exacerbations, who received treatment with AB-PA01, at the 41st European Cystic Fibrosis Conference in Belgrade, Serbia, in June 2018. Prior to treatment with AB-PA01, the patient received multiple courses of antibiotics, including colistin, but due to renal failure, colistin administration was discontinued. Treatment with AB-PA01 was well tolerated and the patient’s infection resolved. No recurrence of pneumonia or CF exacerbation was reported during the two-month follow-up period after the completion of treatment with AB-PA01. The patient’s renal failure resolved.
Presented a successful case study of a lung transplant recipient suffering from recurrent episodes of MDR P. aeruginosa pneumonia who received treatment with bacteriophage therapeutics, including AB-PA01, at the International Society of Heart and Lung Transplant Annual Meeting in Nice, France, in April 2018. The patient clinically responded to bacteriophage and antibiotic therapy with resolution of pneumonia and improved respiratory status.
Utilized the Therapeutic Development Services funded by the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), to conduct further preclinical studies of AB-SA01. The Therapeutic Development Services program funds the provision of preclinical services for selected companies and researchers in order to advance development of promising interventional agents.
Second Quarter and Six Months Ended June 30, 2018 Financial Results

Research and development (R&D) expenses for the second quarter of 2018 were $1.7 million compared to $1.1 million for the second quarter of 2017, primarily attributable to a $0.2 million increase in professional and consulting fees and a $0.2 million increase in clinical costs.
R&D expenses for the six months ended June 30, 2018 increased by $0.6 million to $3.2 million from $2.6 million for the six months ended June 30, 2017, primarily due to an increase in clinical costs.
General and administrative (G&A) expenses were $1.4 million for the second quarter of 2018 compared to $2.8 million for the second quarter of 2017. The decrease was primarily due to lower payroll-related costs, lower legal and professional fees, as well as a $0.6 million decrease in non-cash stock-based compensation and other non-cash charges.
G&A expenses for the first six months of 2018 decreased by $1.7 million to $3.0 million from $4.7 million for the first six months of 2017. The decrease was primarily attributable to a decrease in the items described above for the second quarter comparison.
Net cash used in operating activities for the six months ended June 30, 2018 was $5.7 million compared to $6.2 million for the six months ended June 30, 2017.
Cash and cash equivalents as of June 30, 2018 totaled $5.8 million.
In July 2018, the Company received $1.2 million of tax rebate incentive payments in cash from the Australian tax authority. The incentive payments are based on R&D activities in Australia in 2017.
As of August 6, 2018, there were 16.5 million shares of common stock outstanding.

Aeterna Zentaris Reports Second Quarter 2018 Financial and Operating Results

On August 9, 2018 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), a biopharmaceutical company engaged in developing and commercializing pharmaceutical products, reported financial and operating results for the second quarter ended June 30, 2018 (Press release, AEterna Zentaris, AUG 9, 2018, View Source [SID1234528747]).

All Amounts are in U.S. Dollars

Recent Key Developments

The Company’s U.S. and Canadian out-licensing partner, Strongbridge Biopharma plc (NASDAQ: SBBP) officially launched our product Macrilen (macimorelin) in the United States effective July 23, 2018. Macrilen is the first and only FDA-approved oral ghrelin receptor agonist to be administered in the diagnosis of patients with adult growth hormone deficiency (AGHD) in the United States.
The Company successfully submitted its required response to the European Medicines Agency (EMA) for the use of macimorelin for the evaluation of AGHD in July 2018.
The Company continues to respond to out-licensing and other commercial partners for other markets globally.
The Company’s financial condition remains strong with $19.9 million of cash and cash equivalents and no debt.
Commenting on recent key developments, Michael V. Ward, President and Chief Executive Officer for Aeterna Zentaris, stated, "We are very pleased with the continued progress being made by the Company in achieving our growth strategy of maximizing the global value of macimorelin. We are also very pleased with the launch of Macrilen in the United States."

Second Quarter Financial Highlights

Cash $19.9 million

Revenues $0.2 million

Research and Development ("R&D") Costs $1.0 million

General and Administrative ("G&A") Expenses $2.0 million

Net loss $2.6 million
The Company will host a conference call to discuss these results on Friday, August 10, 2018, at 8:30 a.m., Eastern Time. Participants may access the conference call by telephone using the following dial-in numbers:

Toll-Free: 877-407-8029, Confirmation #13681858
Toll: 201-689-8029, Confirmation #13681858
A replay of the conference call will also be available on the Company’s website for a period of 30 days. For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the second quarter 2018, as well as the Company’s audited consolidated financial statements as at June 30, 2018, 2017, 2016 and 2015, can be found at www.zentaris.com in the "Investors" section.

Savara Reports Second Quarter 2018 Financial Results and Provides Positive Business Update

On August 9, 2018 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, Savara, AUG 9, 2018, View Source [SID1234528711]).

"We have had an incredibly eventful and productive quarter," said Rob Neville, chief executive officer of Savara. "With two product candidates approaching pivotal data reads and our exploratory NTM program well underway, we believe we are heading into the most exciting twelve months in Savara’s history. Furthermore, the recent acquisition of the assets of Cardeas Pharma Corporation underlines our commitment to our vision to build a prominent orphan lung disease company. With the closing of our recent public offering, we have initiated preparations for Molgradex commercial launch for aPAP, as well as for a new clinical study in CF-affected individuals with chronic NTM infection, and will support our exploratory pipeline."

Upcoming Milestones and Recent Developments

Anticipating completion of enrollment in the Molgradex Phase 3 IMPALA study in Q3 2018. The IMPALA study is evaluating our inhaled formulation of granulocyte-macrophage colony-stimulating factor, or GM-CSF, for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP. At the end of Q2, enrollment was at 106 patients out of a total target of 135 patients, with completion of enrollment currently on track for Q3 2018 and topline data anticipated in Q2 2019.

Encouraging patient enrollment in the Molgradex IMPALA-X safety extension study. The IMPALA-X study is an open-label, multicenter study designed to determine the long-term safety and utilization of Molgradex in patients with aPAP. IMPALA-X offers patients the opportunity to continue treatment with Molgradex for up to three years after completion of the pivotal Phase 3 IMPALA study. Of the 14 subjects eligible to enroll into IMPALA-X at the end of Q2, 12 have enrolled to date, while the remaining 2 subjects are expected to enroll shortly.

Anticipating completion of enrollment in the Molgradex Phase 2a OPTIMA study in Q3 2018. The OPTIMA study is evaluating our inhaled GM-CSF for the treatment of nontuberculous mycobacterial (NTM) lung infection. At the end of Q2, enrollment was at 17 patients out of a total target of 30 patients, and completion of enrollment remains on track for Q3 2018. Interim results are anticipated in Q4 2018, and topline data anticipated in Q2 2019.

Anticipating completion of enrollment in the AeroVanc Phase 3 AVAIL study in Q1 2019. The AVAIL study is evaluating our vancomycin hydrochloride inhalation powder for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in individuals affected by cystic fibrosis. At the end of Q2, enrollment was at 107 patients out of a total target of 200 patients, with completion of enrollment currently on track for Q1 2019 and topline data anticipated in H2 2019.

Provided positive update on the development and commercialization of Molgradex. Savara has received positive investigator feedback on treatment with Molgradex in the open label portion of the IMPALA study, as well as a high interest in participation in the IMPALA-X study. The Company believes the high enrollment rates into the IMPALA-X study gives important insight into the level of satisfaction with Molgradex. Driven by its confidence in the outcome of the IMPALA study, Savara will expedite its preparation for potential commercial launch with investments into core commercial leadership and staff, as well as external activities required for a successful launch. Assuming robust results from the IMPALA study and subsequent breakthrough and/or fast track designation, submission of the Molgradex Biologic License Application, or BLA, is anticipated in the first half of 2020, with a resultant commercial launch in late 2020 or early 2021.

Announced expansion of the Molgradex program, with a Phase 2a clinical study in the U.S. in CF-affected individuals with chronic NTM lung infection expected to begin in Q1 2019. Savara is preparing to initiate a new open-label study in the U.S., which will enroll 30 subjects with chronic Mycobacterium abscessus (M. abscessus) or Mycobacterium avium complex (MAC) infection. The study will comprise a 48-week treatment period and a 24-week follow-up period. The primary endpoint in the study will be NTM sputum culture conversion to negative.

Launched exploratory product pipeline, announced the acquisition of the assets of Cardeas Pharma Corporation and the appointment of A. Bruce Montgomery, M.D., as strategic advisor. As part of Savara’s commitment to growth through innovation and acquisition, the Company launched its exploratory pipeline, focused on pre-proof-of-concept, high-potential programs in difficult-to-treat lung diseases, and announced the acquisition of Cardeas Pharma’s Phase 2 ready aerosolized amikacin/fosfomycin, a proprietary combination antibiotic. In connection with the acquisition, Savara appointed Dr. A. Bruce Montgomery, a leading pioneer in the field of inhaled antibiotics and other orphan lung disease products, as strategic advisor.

Successfully closed a public offering with gross proceeds of approximately $48.9 million. The offering was led largely by existing shareholders along with new institutional healthcare investors. The proceeds of the offering will be used for working capital and general corporate purposes, including helping to fund commercial preparatory efforts for Molgradex in aPAP, launching a new clinical study in CF-affected individuals with chronic NTM infection, and supporting Savara’s exploratory pipeline.
Second Quarter Financial Results

Savara’s net loss attributable to common shareholders for the three months ended June 30, 2018 was $11.6 million, or $(0.38) per share, compared with a net loss attributable to common shareholders of $12.5 million, or $(0.90) per share, for the three months ended June 30, 2017.

Research and development expenses were $9.3 million for the three months ended June 30, 2018, compared with $4.2 million for the three months ended June 30, 2017. This increase was due to several factors, including $2.3 million in additional expenses associated with the AeroVanc Phase 3 study activities; $1.8 million in development costs of Molgradex, including the expansion of the aPAP study in the U.S. and costs associated with the Phase 2 NTM study; and $1 million in expense related to the acquisition of assets from Cardeas.

General and administrative expenses for the three months ended June 30, 2018 were $2.5 million, compared with $5.1 million for the three months ended June 30, 2017. For the three months ended June 30, 2017, the Company recorded a $1.9 million change in fair value of the contingent consideration associated with its acquisition of Serendex compared to only $0.1 million for the three months ended June 30, 2018. In the second quarter of 2017, the Company incurred $1.7 million in expense associated with its merger transaction with Mast Therapeutics, Inc. (the "Merger") in April 2017, none of which was incurred in the second quarter of 2018. In the second quarter of 2018, Savara incurred approximately $0.9 million in additional costs related to personnel and other expenditures associated with public company requirements and activities. Other expense decreased by $2.7 million for the three months ended June 30, 2018 as compared to the same period in 2017. This decrease was primarily due to the second quarter of 2017 having $1.8 million of expense associated with the extinguishment of certain pre-Merger convertible promissory notes.

As of June 30, 2018, Savara had a debt balance of approximately $15.0 million and had cash, cash equivalents and short-term investments of approximately $74.8 million.

Conference Call and Webcast
Savara will hold a conference call today beginning at 5:30pm Eastern Time / 4:30pm Central Time to provide a business update. Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the Savara Inc. call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source Replays of the webcast will be available on Savara’s website for 30 days and a telephone replay will be available through August 16, 2018 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. and entering replay access code 10122221.

CymaBay Reports Second Quarter 2018 Financial Results and Provides Corporate Update

On August 9, 2018 CymaBay Therapeutics, Inc. (NASDAQ: CBAY) a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter and six months ended June 30, 2018 (Press release, CymaBay Therapeutics, AUG 9, 2018, View Source [SID1234528710]).

"Having completed a significant capital raise to start the year, we are now laser focused on high quality execution as we continue to advance novel treatment alternatives to patients suffering from liver diseases with significant unmet needs," said Sujal Shah, President and Chief Executive Officer of CymaBay. "We have collected feedback from regulatory agencies and finalized our design for our planned Phase 3 study of seladelpar in primary biliary cholangitis (PBC) and we are on track to initiate this study in the second half of the year. Data from the ongoing Phase 2 study of seladelpar in patients with PBC were presented in a late-breaking presentation at The International Liver CongressTM in April, and we believe these data support the potential of seladelpar to provide improved efficacy and better tolerability over existing second-line therapy. We are also excited to expand development of seladelpar into non-alcoholic steatohepatitis (NASH) with the recent initiation of a Phase 2b proof-of-concept study. We believe seladelpar’s PPAR-delta mechanism of action may be particularly well suited to treat NASH given its beneficial impacts on lipid, glucose, and sterol metabolism, as well as its effects on inflammation and fibrogenesis."

Second Quarter 2018 Business Highlights

Announced plans to proceed with a double-blind, placebo-controlled Phase 3 pivotal study of seladelpar in PBC. The study intends to enroll approximately 240 patients randomized to receive either 5 mg or 10 mg seladelpar, or placebo. Patients who have an inadequate response on the 5 mg dose will have the potential to increase to 10 mg after 6 months.
Presented new 12-week and 26-week results from the ongoing Phase 2 study of seladelpar in primary biliary cholangitis (PBC) at The International Liver CongressTM in April.
• The results showed potent anti-cholestatic and anti-inflammatory activities, with no drug-induced pruritus, through 26 weeks of treatment.
• 52-week data from this study are expected to be announced in the fourth quarter of 2018.
Initiated a Phase 2b proof-of-concept study of seladelpar for the treatment of NASH. This randomized, placebo-controlled, parallel, dose-ranging study is intended to enroll approximately 175 patients with liver biopsy proven NASH. The primary efficacy outcome is change in liver fat content from baseline to 12 weeks as measured by magnetic resonance imaging. The secondary analysis includes evaluation of histological improvement in NASH and fibrosis as assessed by comparing liver biopsy samples taken at baseline and 52 weeks.
Added CBAY to the Russell 3000 and the Russell 2000 Indexes at the conclusion of the Russell US Indexes annual reconstitution.
Expanded workforce with clinical, regulatory, scientific and administrative personnel necessary to support expansion of clinical programs, notably the Phase 3 PBC registration study, and business operations.
Amended the existing corporate office lease to extend it for an additional 5-year term and relocate to a larger facility within current corporate campus location.
Second Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities totaled $212.1 million at June 30, 2018. Based on current projections, existing cash is expected to fund the current operating plan into 2021.
Term loan facility repaid in full resulting in a debt-free balance sheet at June 30, 2018.
No collaboration revenue was recognized in the second quarter of 2018.
Research and development expenses were $14.4 million in the second quarter of 2018 as compared to $4.0 million in the same period of 2017 and consisted primarily of higher clinical trial expenses related to ongoing PBC Phase 2 and extension studies, start-up activities for the planned PBC Phase 3 study, and enrollment activities associated with the recently initiated NASH Phase 2b study. Additionally, higher seladelpar drug manufacturing expenses were incurred to provide clinical supplies to these studies.
General and administrative expenses were unchanged at $3.6 million in the second quarter of 2018 and 2017.
Net loss was $17.5 million, or ($0.30) per share in the second quarter of 2018, as compared to $8.9 million, or ($0.31) per share in the second quarter of 2017. Net loss was higher primarily due to increased research and development expenses incurred to support expanding clinical studies.
First Half 2018 Financial Results

No collaboration revenue was recognized in the first half of 2018 as compared to $4.8 million in the same period of 2017. Revenue associated with the collaboration arrangement with Kowa Pharmaceuticals America was recognized in 2017 upon transfer of a license and know how to Kowa.
Research and development expenses were $23.9 million in the first half of 2018 as compared to $8.1 million in the same period of 2017 and consisted primarily of higher clinical trial expenses related to ongoing PBC Phase 2 and extension studies, start-up activities for the planned PBC Phase 3 study, and enrollment activities associated with the recently initiated NASH Phase 2b study. Additionally, higher seladelpar drug manufacturing expenses were incurred to provide clinical supplies to these studies.
General and administrative expenses were $6.9 million in the first half of 2018, as compared to $7.3 million in the first half of 2017. Expenses were higher in 2017 primarily due to severance expenses associated with the retirement of CymaBay’s former CEO.
Net loss was $34.5 million, or ($0.61) per share in the first half of 2018, as compared to $14.3 million, or ($0.52) per share in the second quarter of 2017. Net loss was higher primarily due to increased research and development expenses incurred to support the expanding clinical studies and lower collaboration revenue.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2018 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13680965. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source